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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMYSENTRY SYSTEM, MYSENTRY MONITOR, MYSENTRY OUTPOST
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS157
Date Received06/18/2014
Decision Date07/18/2014
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF A FUNCTIONAL TEST DURING MANUFACTURE OF THE MYSENTRY SYSTEM (MMT-9100). THE MYSENTRY SYSTEM (MMT-9100) CONSISTS OF THE MYSENTRY MONITOR (MMT-9101) AND MYSENTRY OUTPOST (MMT-9102) AND IS APPROVED FOR USE WITH THE PARADIGM REALTIME REVEL SYSTEM.
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